Patients living with fatty liver disease finally have FDA-approved treatment for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). 

NASH/MASH is the fastest-growing cause of cirrhosis, liver cancer, and liver transplant. FDA-approved medication is one tool to treat an advanced stage of this serious, progressive disease, particularly for patients with moderate to advanced liver scarring, thereby preventing liver transplants and reducing the incidence of liver cancer.

The FDA intentionally has not recommended or required a liver biopsy when prescribing approved NASH/MASH medication. This decision reflected the FDA’s responsiveness to the voices of patients from Global Liver Institute’s Externally-Led, Patient-Focused Drug Development Meeting in 2022 and the impact of the Beyond the Biopsy collaborative. Approval of medication for NASH/MASH would give patients and healthcare providers a long-awaited tool to change the trajectory of their chronic liver disease. Criteria that calls for a biopsy would serve as a significant hurdle to needed treatment.

Insurers, please follow FDA and clinical guidelines and do not make biopsy a hurdle to needed NASH/MASH treatment!